ISO 15189-2022 PDF

Full title and description

ISO 15189:2022 — Medical laboratories — Requirements for quality and competence. This fourth edition of ISO 15189 specifies management‑system and technical requirements that medical laboratories must meet to ensure the quality, reliability and clinical usefulness of patient testing and related services; it explicitly covers point‑of‑care testing (POCT) and consolidates POCT requirements previously covered in ISO 22870.

Abstract

ISO 15189:2022 defines requirements for a medical laboratory’s quality management system and for technical competence in all stages of the testing process (pre‑examination, examination and post‑examination). It is intended for use by laboratories developing their management systems, by accreditation bodies and regulators assessing laboratory competence, and by laboratory users seeking confirmation of competence. The standard emphasizes clinical risk, patient safety, leadership and governance, and aligns the structure of medical‑laboratory requirements with other ISO conformity‑assessment standards.

General information

• Status: Published.
• Publication date: 6 December 2022.
• Publisher: International Organization for Standardization (ISO), developed by ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems).
• ICS / categories: 03.120.10 (Quality management and quality assurance); 11.100.01 (Laboratory medicine in general).
• Edition / version: 4th edition (2022).
• Number of pages: 62 pages.

Key bibliographic and status details above are taken from ISO’s published record for ISO 15189:2022.

Scope

ISO 15189:2022 applies to medical laboratories of all types and sizes that undertake examinations and provide results for diagnosis, prevention and treatment of disease. The standard covers requirements for the laboratory management system and for technical competence across the total testing process, including sample collection, transport, handling, analytical procedures, result validation and reporting. Point‑of‑care testing (POCT) requirements are incorporated into this edition, making the standard applicable to distributed testing environments as well as central laboratories. The standard may be used for accreditation, regulatory recognition or internal quality improvement.

Key topics and requirements

• Laboratory management system: leadership, documented policies, objectives, organizational structure and responsibilities.
• Risk management and patient safety: identification and mitigation of clinical risks arising from laboratory testing and result use.
• Personnel competence: qualifications, training, assessment of competence and continuing education.
• Pre‑analytical, analytical and post‑analytical processes: procedures for specimen collection, handling, verification, result validation and reporting.
• Method validation and verification, measurement uncertainty and traceability for quantitative assays.
• Equipment and reagent management: installation, maintenance, calibration and records.
• Quality control and external quality assessment (proficiency testing): statistical QC, acceptance criteria and corrective actions.
• Information management and interoperability: reporting formats, secure data handling and interfaces with clinical systems.
• POCT governance: oversight, training, connectivity and quality control for tests performed outside central lab locations.
• Internal audits, management review and continual improvement processes.
• Requirements for working with accreditation bodies, regulators and laboratory users to demonstrate competence.

Typical use and users

Primary users are medical laboratory directors, quality managers, technical supervisors and POCT programme managers preparing for accreditation or seeking to enhance laboratory quality and patient safety. Accreditation bodies and regulators use ISO 15189 as the benchmark for assessing medical laboratory competence. Hospitals, primary‑care clinics, independent diagnostic laboratories and organisations that operate distributed POCT networks also use the standard to design governance, training and quality programmes.

Related standards

ISO 15189:2022 consolidates POCT requirements previously in ISO 22870:2016 and is commonly considered alongside ISO/IEC 17025 (competence of testing and calibration laboratories) and ISO 15190 (medical laboratory safety). Laboratories also map relevant management system elements to generic standards such as ISO 9001 where useful. An amendment (EN ISO 15189:2022/A11:2023) and national/adopted versions exist in some regions.

Keywords

medical laboratory, quality management, accreditation, competence, point‑of‑care testing, POCT, pre‑analytical, analytical, post‑analytical, risk management, clinical laboratory, ISO/TC 212.

FAQ

Q: What is this standard?

A: ISO 15189:2022 is an international standard that specifies requirements for the quality management system and technical competence of medical laboratories, intended for use in accreditation and quality assurance of clinical diagnostic services.

Q: What does it cover?

A: It covers management and technical requirements across the total testing process (pre‑, intra‑ and post‑analytical), personnel competence, equipment and reagent management, method validation/verification, quality control, information management, and POCT governance; it also emphasizes clinical risk and patient safety.

Q: Who typically uses it?

A: Medical laboratory directors, quality and technical managers, POCT coordinators, accreditation bodies, regulators and healthcare providers that rely on laboratory results for patient care.

Q: Is it current or superseded?

A: ISO 15189:2022 is the current, published edition (4th edition, published 6 December 2022), which supersedes ISO 15189:2012; POCT requirements from ISO 22870:2016 are incorporated into this edition. Note that a three‑year transition period for accreditation to the new edition was adopted following publication, ending on 6 December 2025.

Q: Is it part of a series?

A: ISO 15189 is part of the family of standards and guidance for laboratory quality and safety produced by ISO/TC 212 and is used alongside related standards such as ISO/IEC 17025 (testing/calibration labs), ISO 15190 (laboratory safety) and ISO 22870 (POCT — now consolidated into 15189). National and regional adoptions (EN, SRPS, etc.) and amendments may also apply.

Q: What are the key keywords?

A: medical laboratory, accreditation, quality management, competence, POCT, patient safety, risk management, method validation, quality control, ISO 15189:2022.